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Lutathera is FDA approved as first medicine specifically for pediatric patients with gastro-enteropancreatic neuroendocrine tumors – Novartis

Written by | 27 Apr 2024

Novartis announced that the FDA approved Lutathera (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with… read more.

Kesimpta (ofatumumab) six-year efficacy data show substantial benefits in recently diagnosed treatment-naïve people with relapsing multiple sclerosis – Novartis

Written by | 20 Apr 2024

Novartis announced new long-term data from the ALITHIOS open-label extension study showing that up to five years, patients treated earlier and continuously with Kesimpta (ofatumumab) had fewer disability… read more.

New data shows early addition of twice-yearly Leqvio (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting – Novartis

Written by | 12 Apr 2024

Novartis announced new data demonstrating the early addition of twice-yearly Leqvio (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density… read more.

Fabhalta (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria – Novartis

Written by | 27 Mar 2024

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing… read more.

New data is presented at MDA meeting of Zolgensma (onasemnogene abeparvovec) from the SMART study for the treatment of spinal muscular atrophy – Novartis

Written by | 11 Mar 2024

Novartis presented new data that continue to support the clinical benefits of Zolgensma (onasemnogene abeparvovec), the only one-time gene therapy for the treatment of spinal muscular atrophy (SMA)…. read more.

FDA approves Xolair as first and only medicine for children and adults with one or more food allergies – Genentech/Roche + Novartis

Written by | 20 Feb 2024

Roche announced that the FDA has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods… read more.

FDA approves Cosentyx as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases – Novartis

Written by | 22 Oct 2023

Novartis,, announced that the FDA has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic… read more.

Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer

Written by | 12 Oct 2023

Novartis will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) Congress 2023, highlighting latest developments from across its oncology… read more.

Novartis completes divestment of ‘front of eye’ ophthalmology assets

Written by | 3 Oct 2023

Novartis announced that it has completed its divestment of ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up… read more.

European Commission approves Tyruko (natalizumab biosimilar), first and only biosimilar for multiple sclerosis in Europe – Sandoz

Written by | 2 Oct 2023

Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by… read more.

Leqvio (inclisiran) is approved by MHLW for familial and non-familial hypercholesterolemia and for patients who are at a high risk of developing cardiovascular events – Novartis

Written by | 1 Oct 2023

Leqvio (inclisiran), became the first siRNA therapy for dyslipidemia approved in Japan. The drug was approved for familial and non-familial hypercholesterolemia and is intended for patients who are… read more.

CHMP positive for Finlee + trametinib for the treatment of low and high grade glioma – Novartis

Written by | 26 Sep 2023

On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.

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